Events

Recall of Device Recall Shiley

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Nellcor Puritan Bennett Inc. (dba Covidien LP).

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    62559
  • Event Risk Class
    Class 1
  • Event Number
    Z-2174-2012
  • Event Initiated Date
    2012-07-18
  • Event Date Posted
    2012-08-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-01-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=111017
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Tube tracheostomy and tube cuff - Product Code JOH
  • Reason
    Covidien is recalling certain cuffed shiley tracheostomy tubes due to consumer complaints related to the connections and functions of the inner and outer cannula which were observed during mechanical ventilation of patients.
  • Action
    Covidien sent an Urgent Medical Device Recall letter dated July 18, 2012 to all affected consignees via mail (FedEx) notification. The customer communication identified the affected product , problem and actions to be taken. Customers were instructed to examine their inventory, segregate product with the identified affected product codes and lot numbers and complete the enclosed verification form and fax to 925-463-4600. Customers were asked to return unused products from the affected product codes and lots. The firm also recommended the replacement of affected tubes that were already in use as soon as clinically appropriate. The letter stated to return the affected product for credit or question contact Technical Services group at 800-635-5267 option 3, option 1 and reference the Return Goods Authorization number.

Device

Device Recall Shiley
  • Model / Serial
    United States distributed product includes: 8FEN lots 0910000342 to 1101001558 and 110300622X to 120600700X; 8LPC lots 0910000348 to 1101001823 and 110200327X to 120600351X.  Product Distributed outside of the United States: 8FENJ lots 1003002176, 1004000412, and 120100433X. 8FEN-S lot 0910001010; 8FENJ-S lots 0910002075 to 1103002299 and 110601803X to 120402125X; and 8LPC-S lots 0910001002 to 1103002052 and 111000400X to 120600014X.
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Nationwide
  • Product Description
    Shiley Reusable Cannula Low Pressure Cuffed Tracheostomy Tubes, model numbers (Worldwide) 8LPC, 8FEN; (Outside U.S.) 8FENJ, 8FENJ-S, 8LPC-S, 8FEN-S. || Product Usage: The product is intended for use to bypass upper airway obstructions, provide long term ventilation, support and/or manage tracheal/bronchial secretions. The product is sold as sterile. The packaging may indicate either Covidien or Tyco as the manufacturer as the firm has transitioned from Tyco to Covidien over the past 4 years.
  • Manufacturer
    Nellcor Puritan Bennett Inc. (dba Covidien LP)

Manufacturer

Nellcor Puritan Bennett Inc. (dba Covidien LP)
  • Manufacturer Address
    Nellcor Puritan Bennett Inc. (dba Covidien LP), 6135 Gunbarrel Ave, Boulder CO 80301-3214
  • Manufacturer Parent Company (2017)
    Medtronic plc
  • Manufacturer comment
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA